Completed PHASE3 INTERVENTIONAL 3-arm NCT00958308

Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

A Double-blind, Randomized, Placebo-controlled, Single-center Study of the Efficacy and Safety of BIO-K+ CL-1285® in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection

Sponsor: Bio-K Plus International Inc.

Conditions Antibiotic-Associated Diarrhea Clostridium Difficile-Associated Diarrhea

Interventions BIO-K+ CL-1285® Placebo

Updated 7 times since 2017 Last updated: Mar 9, 2012 Started: Dec 31, 2008 Primary completion: Mar 31, 2009 Completion: Apr 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Antibiotic-Associated Diarrhea and Clostridium Difficile-Associated Diarrhea and is currently completed. Bio-K Plus International Inc. leads this study, which shows 7 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3
Jan 2021 — Dec 2022 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Dec 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bio-K Plus International Inc.
Sprim Advanced Life Sciences

Data source: Bio-K Plus International Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.